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01 1ALLERGAN
02 2MANKIND PHARMA
03 1ALTAIRE PHARMS INC
04 2ALVOGEN
05 2AMNEAL
06 2APOTEX INC
07 2BAUSCH AND LOMB
08 1BEDFORD
09 3CADILA PHARMS LTD
10 2CAPLIN
11 3CHARTWELL RX
12 1DAIICHI
13 3DR REDDYS LABS LTD
14 1EPIC PHARMA LLC
15 2FDC LTD
16 1HIKMA
17 3JANSSEN PHARMS
18 5ORTHO MCNEIL PHARM
19 3RANBAXY LABS LTD
20 3SANDOZ
21 1SENTISS
22 1SOMERSET
23 1SOMERSET THERAPS LLC
24 3TEVA
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01 6INJECTABLE;INJECTION
02 14SOLUTION/DROPS;OPHTHALMIC
03 11SOLUTION/DROPS;OTIC
04 18TABLET;ORAL
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01 24DISCN
02 25RX
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01 5FLOXIN
02 1FLOXIN IN DEXTROSE 5%
03 2FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
04 1FLOXIN OTIC
05 1OCUFLOX
06 39OFLOXACIN
01 44No
02 5Yes
RLD : Yes
TE Code : AT
Brand Name : OCUFLOX
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.3%
Approval Date : 1993-07-30
Application Number : 19921
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AT
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AT
Brand Name : OFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.3%
Approval Date : 2022-11-23
Application Number : 215886
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AT
Brand Name : OFLOXACIN
Dosage Form : SOLUTION/DROPS;OTIC
Dosage Strength : 0.3%
Approval Date : 2022-07-14
Application Number : 216130
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
RLD : Yes
TE Code :
Brand Name : FLOXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1990-12-28
Application Number : 19735
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FLOXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1990-12-28
Application Number : 19735
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FLOXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1990-12-28
Application Number : 19735
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : FLOXIN IN DEXTROSE 5%
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 400MG/100ML
Approval Date : 1992-03-31
Application Number : 20087
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : FLOXIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML
Approval Date : 1992-03-31
Application Number : 20087
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : FLOXIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 40MG/ML
Approval Date : 1992-03-31
Application Number : 20087
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4MG/ML
Approval Date : 1992-03-31
Application Number : 20087
RX/OTC/DISCN : DISCN
RLD : No
TE Code :